Effects of SinuSonic on Psychological and Physical Well-Being

Last updated: August 22, 2024
Sponsor: University of North Carolina, Chapel Hill
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammation

Treatment

SinuSonic

Clinical Study ID

NCT06268730
23-2437
  • Ages 18-99
  • All Genders

Study Summary

The goal of this clinical trial is to evaluate the effects of using the SinuSonic on psychological and physical well-being in adults who have nasal/sinus congestion.

The study aims are:

  • Aim #1: to evaluate the effect of the SinuSonic on physical and psychological well-being in individuals with chronic nasal congestion;

  • Aim #2: to evaluate the relationship between autonomic reactivity and psychological well-being (i.e., anxiety and depression) in individuals with chronic nasal congestion;

  • Exploratory Aim: to evaluate the impact of adverse experiences on physical and psychological well-being in individuals who experience chronic nasal congestion.

Participants will be asked to complete self-report measures of physical health, mental health and autonomic regulation before using SinuSonic (i.e., baseline research session) and after 5 weeks of directed use (post-intervention). Demographic information and adverse experiences will be documented during the baseline research session. Participants will be asked to document (weekly) current nasal symptoms and SinuSonic usage.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years or older;

  • US resident;

  • Currently experiencing symptoms of nasal congestion that have persisted at least 2weeks. Symptom severity must be rated at least 5, on a visual scale ranging from 1to 10, as included in a question in the Eligibility Screening.

Exclusion

Exclusion Criteria:

  • Previous use of the SinuSonic device.

  • Meeting any of the conditions listed under the "Safety and Warnings" for using theSinuSonic device:

  1. Current or history of breathing problems (i.e., asthma, chronic obstructivepulmonary disorder (COPD), chronic bronchitis, emphysema, pneumonia, pleuraleffusion, lung cancer, cancer of the throat or upper airway)

  2. Current or history of circulatory problems (i.e., active nose bleed, heartarrhythmia, coronary artery disease, congestive heart failure, heart attack)

  3. Other conditions, specified as brain tumor, moderate to severe ear pain, fevergreater than 101 degrees

  4. Pregnant or nursing women

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: SinuSonic
Phase:
Study Start date:
April 08, 2024
Estimated Completion Date:
March 31, 2025

Study Description

All data collection will occur remotely using REDCap (via University of North Carolina, Chapel Hill) and SinuSonic use will take place in participants' homes. As this is a single-arm, feasibility/pilot study, all participants will follow the same protocol.

  1. Baseline Research Session: self-report completion of demographic information, health information [Short Form Health Survey (SF-20), Total Nasal Symptom Score (TNSS)], autonomic reactivity (Body Perception Questionnaire, BPQ), anxiety/depression (Hospital Anxiety and Depression Scale, HADS), and adverse experiences (Adverse Traumatic Experiences Scale, ATES).

  2. Begin use of SinuSonic twice per day, every day, for 5 weeks. Duration of each use is approximately 2 minutes. During these 5 weeks, participants will be asked to complete weekly forms to document SinuSonic usage and current nasal symptoms [Patient Global Impression of Change (PGIC), Total Nasal Symptom Score (TNSS).

  3. Post-intervention Research Session: after 5 weeks of SinuSonic use, self-report completion of symptoms (PGIC, TNSS), autonomic reactivity (BPQ) and anxiety/depression (HADS).

Connect with a study center

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599-7160
    United States

    Active - Recruiting

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